Formulation of Rupataget Tab
Rupatadine
Rupatadine is a second generation, non-sedating, long-acting histamine antagonist with selective peripheral H₁ receptor antagonist activity. It further blocks the receptors of the platelet-activating factor (PAF) according to in vitro and in vivo studies.Rupatadine possesses anti-allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non-immunological stimuli, and inhibition of the release of cytokines, particularly of the tumor necrosis factors (TNF) in human mast cells and monocytes.Rupatadine is an anti-allergenic and acts to reduce allergic symptoms like urticaria, rhinorrhea, sneezing and itching
Rupataget Tab is used for the symptomatic treatment of seasonal & perennial allergic rhinitis and urticaria.Rupataget is also used toassociated treatment for these conditions: Allergic Rhinitis (AR), Pruritus, Urticaria. It blocks histamine action, which reduces allergy symptoms.
Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.
Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.Children aged 2 to 11 years: Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food. Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.
Precautions
The administration of Rupatadine with grapefruit juice is not recommended. The combination of Rupatadine with potent CYP3A4 inhibitors should be avoided and with moderate CYP3A4 inhibitors should be administered with caution. Dose adjustment of sensitive CYP3A4 substrates (e.g., simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic index (e.g., ciclosporin, tacrolimus, sirolimus, everolimus, cisapride) could be required as Rupatadine may increase plasma concentrations of these drugs. Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). Due to the presence of lactose monohydrate in Rupatadine tablets, patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine. The use of Rupatadine in patients with renal impairment or hepatic impairment is not recommended. Rare hypersensitivity reactions (including anaphylactic reactions, angioedema, and urticaria) have been reported in post-marketing experience with Rupatadine.
Overdosage
The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.
Storage
Store in cool & dry place below 30 °C, protect from light & moisture. Keep out of reach of children.